Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Depression, Bipolar

Treatments: Drug: Cariprazine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396447

RGH-MD-56

2011-002334-39 (EudraCT Number)

Details and patient eligibility

About

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

Enrollment: 584 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who have provided informed consent prior to any study specific procedures.
• Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
• Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
• Verified previous manic or mixed episode.
• Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
• Participants with a HAMD-17 item 1 score ≥ 2.
• Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion criteria

• Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
• Women who are pregnant or breast feeding
• Participants with Young Mania Rating Scale (YMRS) total score > 10
• Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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584 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo orally once a day for 8 weeks.

Treatment:

Drug: Placebo

Cariprazine 0.75 mg

Experimental group

Description:

Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.

Treatment:

Drug: Cariprazine

Cariprazine 1.5 mg

Experimental group

Description:

Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.

Treatment:

Drug: Cariprazine

Cariprazine 3.0 mg

Experimental group

Description:

Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.

Treatment:

Drug: Cariprazine